DEVICE: StatSensor/StatStrip (00385480544221)

Device Identifier (DI) Information

StatSensor/StatStrip
1.0
In Commercial Distribution
54422
NOVA BIOMEDICAL CORPORATION
00385480544221
GS1

1
070617139 *Terms of Use
StatStrip StatSensor Remanufactured Wireless Carrying Case for Meter and Supplies v1.0
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Home-use/point-of-care blood glucose monitoring system IVD A collection of devices including a portable, battery-powered, semi-automated or automated instrument (self-testing meter), reagents, test strips and/or other associated materials and accessories (e.g., control solutions, lancets) intended to be used together for testing, either at the point-of-care or self-testing by a layperson, for the quantitative measurement of glucose in a whole blood clinical specimen. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
KHP ACID, LACTIC, ENZYMATIC METHOD
CGL ELECTRODE, ION BASED, ENZYMATIC, CREATININE
CGA GLUCOSE OXIDASE, GLUCOSE
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K150281 000
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

06ff9df3-faff-434c-a89d-5d1e9f320b74
July 06, 2018
3
September 20, 2016
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
10385480544228 1 00385480544221 In Commercial Distribution carton
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
No
Yes
Yes
Yes
No CLOSE

Customer Contact

[?]
+1(180)054-5668
info@novabio.com
CLOSE